Breathable interface system for topical reduced pressure

ABSTRACT

A breathable interface system including an applicator having an aperture therethrough; a drape substantially covering the applicator; a first pad section located between the drape and the applicator; a second pad section substantially covering the aperture and located between the drape and the applicator, the second pad section substantially adjacent to the first pad section; and a fabric layer located at least partially between the second pad section and the drape; and a reduced pressure conduit in communication with one of the first pad section and the fabric layer for providing reduced pressure to the aperture; wherein the drape is secured to the applicator, covering the first pad section, the second pad section, and the fabric layer in a substantially sealed environment.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.60/900,463, filed Feb. 9, 2007, which is hereby incorporated byreference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present application relates generally to systems and methods forproviding reduced pressure tissue treatment to open wounds and othertissue sites. More particularly, the present application relates to abreathable interface systems for topical reduced pressure.

2. Description of Related Art

Clinical studies and practice have shown that providing a reducedpressure in proximity to a tissue site augments and accelerates thegrowth of new tissue at the tissue site. The applications of thisphenomenon are numerous, but application of reduced pressure has beenparticularly successful in treating wounds and tissue sites. Thistreatment (frequently referred to in the medical community as “negativepressure wound therapy,” “reduced pressure therapy,” or “vacuumtherapy”) provides a number of benefits, including faster healing, andincreased formulation of granulation tissue.

Reduced pressure tissue treatment has recently been popularized byKinetic Concepts, Inc. of San Antonio, Tex., through its commerciallyavailable VAC reduced pressure tissue treatment systems product line. Ingeneral, such reduced pressure tissue treatment systems comprise apad-based dressing, which is applied to the tissue and is sometimesreferred to as the “tissue interface” or the “wound interface.”

Current dressings, however, have several disadvantages. They aredifficult to apply to small wounds, and often lead to maceration of thewound periphery. Traditionally, dressings have been rather cumbersome,limiting many patient activities. Simply sitting on or rolling onto adressing may cause significant patient discomfort. Moreover, theseactions may compress the dressing and interfere with the application ofreduced pressure to a manifold at the tissue site.

SUMMARY

The problems presented with these conventional dressings are solved byan improved breathable interface system for topical reduced pressure.One illustrative embodiment of the breathable interface system includesa first pad section, a second pad section, and a fabric layer, allpositioned between a drape and an applicator. In addition, the dressingmay include an interface component to facilitate fluid connection of aconduit to the dressing. Alternatively, a conduit may be placed indirect contact with or inserted directly into the dressing to deliverreduced pressure that is then distributed to a tissue site through thefabric layer and the pad sections.

In another illustrative embodiment, the breathable interface system mayinclude a layer having a high moisture vapor transmission rate, whichrapidly removes moisture from the periphery of the tissue site andinsulates the periphery from exudate removed from the tissue site. Thus,these illustrative embodiments substantially eliminate or reducemaceration around a tissue site during reduced pressure tissuetreatment, particularly around small tissue sites.

These and other illustrative embodiments also may include a fabric layerthat provides additional fluid pathways that are less susceptible tocollapsing under higher compressive loads, thereby improving theperformance of reduced pressure tissue treatment in active patients.These additional fluid pathways also reduce the time to distributereduced pressure to a tissue site, which enhances the effectiveness ofintermittent reduced pressure tissue treatment.

One illustrative embodiment includes a breathable interface systemincluding an applicator having an aperture therethrough; a drapesubstantially covering the applicator; a first pad section locatedbetween the drape and the applicator; a second pad section substantiallycovering the aperture and located between the drape and the applicator,the second pad section substantially adjacent to the first pad section;and a fabric layer located at least partially between the second padsection and the drape; and a reduced pressure conduit in communicationwith one of the first pad section and the fabric layer for providingreduced pressure to the aperture; wherein the drape is secured to theapplicator, covering the first pad section, the second pad section, andthe fabric layer in a substantially sealed environment.

Another illustrative embodiment includes a breathable interface systemincluding an applicator having an aperture therethrough; a drapesubstantially covering the applicator; a first pad section locatedbetween the drape and the applicator; a second pad section substantiallycovering the aperture and located between the drape and the applicator,the second pad section substantially adjacent to the first pad section;and a fabric layer located at least partially between the first padsection and the second pad section and the applicator; and a reducedpressure conduit in communication with one of the first pad section andthe fabric layer for providing reduced pressure to the aperture; whereinthe drape is secured to the applicator, covering the first pad section,the second pad section, and the fabric layer in a substantially sealedenvironment.

Yet another illustrative embodiment includes a breathable interfacesystem including an applicator having an aperture therethrough; a drapesubstantially covering the applicator; a first pad section locatedbetween the drape and the applicator; a second pad section substantiallycovering the aperture and located between the drape and the applicator,the second pad section substantially adjacent to the first pad section;and a fabric layer located at least partially between the first padsection and the second pad section and the drape; and a reduced pressureconduit in communication with one of the first pad section and thefabric layer for providing reduced pressure to the aperture; wherein thedrape is secured to the applicator, covering the first pad section, thesecond pad section, and the fabric layer in a substantially sealedenvironment.

Still yet another illustrative embodiment includes a reduced pressuretissue treatment apparatus for applying reduced pressure tissuetreatment to a tissue site including an applicator having an aperturetherethrough; a drape substantially covering the applicator; a first padsection located between the drape and the applicator; a second padsection substantially covering the aperture and located between thedrape and the applicator, the second pad section substantially adjacentto the first pad section; a fabric layer located at least partiallybetween the second pad section and the drape, wherein the drape issecured to the applicator, covering the first pad section, the secondpad section, and the fabric layer in a substantially sealed environment;a reduced pressure conduit in communication with one of the first padsection and the fabric layer for providing reduced pressure to theaperture; and a reduced pressure source in communication with thereduced pressure conduit to deliver reduced pressure to the tissue site.

Other objects, features, and advantages of the illustrative embodimentswill become apparent with reference to the drawings and the detaileddescription that follow.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an exploded view of the breathable interface system accordingto an illustrative embodiment of the invention;

FIG. 2 is a perspective view of the breathable interface system withouta drape according to an illustrative embodiment of the invention;

FIG. 3 is a bottom view of an applicator of a breathable interfacesystem of FIGS. 1 and 2 according to an illustrative embodiment of theinvention;

FIG. 4 is cross-sectional view of the breathable interface system alonglines 4-4 of FIG. 2 according to an illustrative embodiment of theinvention;

FIG. 5 is cross-sectional view of the breathable interface systemaccording to another illustrative embodiment of the invention;

FIG. 6 is cross-sectional view of the breathable interface systemaccording to another illustrative embodiment of the invention;

FIG. 7 is a schematic diagram of a reduced pressure tissue treatmentsystem having a breathable interface system according to an illustrativeembodiment of the invention;

FIG. 8 is a chart that compares the results of pressure transmissionexperiments on a conventional dressing and a breathable interface systemaccording to an illustrative embodiment of the present invention; and

FIG. 9 is a chart that compares response times when subjected tointermittent application of reduced pressure under dry conditions of aconventional dressing and a breathable interface system according to anillustrative embodiment of the present invention.

DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT

In the following detailed description of the preferred embodiments,reference is made to the accompanying drawings that form a part hereof,and in which is shown by way of illustration specific preferredembodiments in which the invention may be practiced. These embodimentsare described in sufficient detail to enable those skilled in the art topractice the invention, and it is understood that other embodiments maybe utilized and that logical, structural, mechanical, electrical, andchemical changes may be made without departing from the spirit or scopeof the invention. To avoid detail not necessary to enable those skilledin the art to practice the invention, the description may omit certaininformation known to those skilled in the art. The following detaileddescription is, therefore, not to be taken in a limiting sense, and thescope of the present invention is defined only by the appended claims.

The term “reduced pressure” as used herein generally refers to apressure less than the ambient pressure at a tissue site that is beingsubjected to treatment. In most cases, this reduced pressure will beless than the atmospheric pressure at which the patient is located.Alternatively, the reduced pressure may be less than a hydrostaticpressure of tissue at the tissue site. Although the terms “vacuum” and“negative pressure” may be used to describe the pressure applied to thetissue site, the actual pressure applied to the tissue site may besignificantly less than the pressure normally associated with a completevacuum. Reduced pressure may initially generate fluid flow in the tubein the area of the tissue site. As the hydrostatic pressure around thetissue site approaches the desired reduced pressure, the flow maysubside, and the reduced pressure is then maintained. Unless otherwiseindicated, values of pressure stated herein are gauge pressures.

The term “tissue site” as used herein refers to a wound or defectlocated on or within any tissue, including but not limited to, bonetissue, adipose tissue, muscle tissue, neural tissue, dermal tissue,vascular tissue, connective tissue, cartilage, tendons, or ligaments.The term “tissue site” may further refer to areas of any tissue that arenot necessarily wounded or defective, but are instead areas in which itis desired to add or promote the growth of additional tissue. Forexample, reduced pressure tissue treatment may be used in certain tissueareas to grow additional tissue that may be harvested and transplantedto another tissue location.

Referring to FIGS. 1-3, an illustrative embodiment of a breathableinterface system 100 is shown. In this embodiment, the breathableinterface system 100 includes a first pad section 102, a second padsection 104, and a fabric layer 106, all positioned between a drape 108and an applicator 110. The breathable interface system 100 generally hasone end 116 that is located substantially adjacent to or over a tissuesite and another end 114 that is located distally away from end 116, inone example. Nearer to end 114, the fabric layer 106 may be positionedor located at least partially between the applicator 110 and the firstpad section 102. Nearer to end 116, the fabric layer 106 may bepositioned or located at least partially between the second pad section104 and the drape 108. The fabric layer 106 extends along a portion of atop surface 124 of the second pad section 104 between the second padsection 104 and the drape 108. Once the fabric layer 106 reaches a side120 of the second pad section 104 it transitions near the area 118between the side 120 of the second pad section 104 and the side 122 ofthe first pad section 102 to extend along a portion of the bottomsurface 126 of the first pad section 102 between the first pad section102 and the applicator 110.

FIG. 2 is an illustrative embodiment of a breathable interface system200 without the drape 108 placed on top of the first pad section 102,second pad section 104, and fabric layer 106 for illustration purposes.The fabric layer 106 can be seen extending over the top surface 124 ofthe second pad section 104 and beneath the bottom surface 126 of thefirst pad section 102. FIG. 3 is an illustrative embodiment of theapplicator 110 including an aperture 302 that extends through theapplicator 110 substantially near the end 116 of the applicator 110. Theaperture 302 preferably is located near a tissue site to enable fluid toflow from the tissue site to the first pad section 102, second padsection 104, fabric layer 106, and reduced pressure conduit 112 of thebreathable interface systems herein described.

In an illustrative embodiment, any hydrogel or bonding agent may beapplied to the aperture 302 and the applicator 110 for sealing orcontact purposes with a tissue site. The second pad section 104 isgenerally positioned to substantially cover the aperture 302, betweenthe drape 108 and the applicator 110 as shown in FIGS. 4 and 6. In FIG.5, the aperture 302 may be substantially covered by the fabric layer 106as described herein. The size of the aperture 302 may vary toaccommodate larger wounds, but in one embodiment, a size of about 10 toabout 20 mm is advantageous for small wounds.

Referring to FIG. 4, an illustrative embodiment of the breathableinterface system 100 is shown. The aperture 302 is shown disposedthrough the applicator 110. In addition, the breathable interface system100 may further include an interface 402 that facilitates fluidcommunication between the first pad section 102 and/or fabric layer 106and the reduced pressure conduit 112. Referring to FIG. 5, anotherillustrative embodiment of the breathable interface system 500 is shown.The breathable interface system 500 may include a different arrangementof the first pad section 102, second pad section 104, and fabric layer106 between the drape 108 and the applicator 110. In this illustrativeembodiment, the fabric layer 106 is located between the bottom surface126 of the first pad section 102 and the bottom surface 128 of thesecond pad section 104 and the top surface 132 of the applicator 110.The first pad section 102 and second pad section 104 are located orpositioned on top of the fabric layer 106. In this illustrativeembodiment, the fabric layer 106 substantially covers the aperture 302.Referring to FIG. 6, yet another illustrative embodiment of thebreathable interface system 600 is shown. In this illustrativeembodiment, the fabric layer 106 is located between the top surface 124of the second pad section 104 and the top surface 130 of the first padsection 102 and the bottom surface 136 of the drape 108.

In any of the breathable interface systems 100, 200, 500, and 600, thereduced pressure conduit 112 may be located in direct contact with thefirst pad section 102 and/or the fabric layer 106. The reduced pressureconduit 112 may be placed in direct contact with the first pad section102 or the fabric layer 106 by directly inserting it into either of thefirst pad section 102 or the fabric layer 106 near the end 114 of thebreathable interface system 100. In another illustrative embodiment, thebreathable interface systems 100, 200, 500, and 600 may further includethe interface 402 as shown in FIG. 4 for facilitating the fluidcommunication and flow between the first pad section 102 and/or fabriclayer 106 and the reduced pressure conduit 112. In yet anotherillustrative embodiment, the reduced pressure conduit 112 may not be indirect contact with the first pad section 102 and/or fabric layer 106,but may otherwise be in fluid communication with the first pad section102 and/or fabric layer 106.

In one illustrative embodiment, the side 120 of the second pad section104 extends between the top surface 124 and a bottom surface 128 of thesecond pad section 104. The bottom surface 128 of the second pad section104 may have a surface area that may cover substantially all or aportion of the top surface 132 of the end 116 of the applicator 110.Additionally, the side 122 of the first pad section 102 extends betweenthe top surface 130 and the bottom surface 126 of the first pad section102. The bottom surface 126 of the first pad section 102 may have asurface area that may cover substantially all or a portion of the end114 of the top surface 132 of the applicator 110.

The applicator 110 may be any size desirable to adequately provideeffective covering and functionality to a tissue site as describedherein. In one aspect, the applicator 110 includes a bottom surface 134that may preferably contact the tissue site. The end 116 of theapplicator 110 may have a surface area of a different shape than the end114 of the applicator 110. For example, the surface area of the end 116as shown in FIG. 1 shows a surface area of a substantially circularshape. Nevertheless, the shape of the end 116 of the applicator 110 mayany desirable shape, symmetric, asymmetric, or otherwise, to provide thecovering of a tissue site and functionality as herein described. In oneillustrative embodiment, the end 114 of the applicator 110 may have asurface area that approximates a rectangular shape; however, the end 114of the applicator 110 may also be any desirable shape, symmetric,asymmetric, or otherwise, to provide the covering and functionality asherein described.

Preferably, the bottom surface 136 of the drape 108 covers and securesthe first pad section 102, fabric layer 106, and second pad section 104to the top surface 132 of the applicator 110. In one aspect, theapplicator 110 and drape 108 are sealed together substantially aroundthe perimeter or periphery of their respective shapes. Preferably, theapplicator 110 and drape 108 isolate the tissue site from itssurrounding environment and maintain a reduced pressure at the tissuesite when reduced pressure is applied as described herein. Theapplicator 110 may be secured to drape 108 with any suitable bondingagent, such as an acrylic adhesive or hydrogel. In addition, theapplicator 110 may be joined to the drape 108 by other commonly knownmeans, such as bonding, adhesives, welding, fastening, and sintering,for example. Typically, a hydrogel or other tissue-friendly bondingagent may be applied to the tissue side or bottom surface 134 of theapplicator 110, which is then placed into the tissue site or in contactwith the perimeter of the tissue site to secure the dressing to thetissue site.

In an illustrative embodiment, the first pad section 102 and second padsection 104 may be a material known in the art to be suitable forreduced pressure tissue treatment, the size and shape of which may bevaried to accommodate tissue sites of various size and shape asdescribed herein. Preferably, the first pad section 102 and second padsection 104 include a plurality of flow channels or pathways tofacilitate the distribution of reduced pressure or fluids to or from thetissue site. In one illustrative embodiment, the first pad section 102and second pad section 104 are porous foam that includes interconnectedcells or pores that act as flow channels. In addition to the above, thefirst pad section 102 and second pad section 104 may be a material suchas an open cell, reticulated foam that is formed from a range ofpolymers, including without limitation polyurethane, polyolefin, vinylacetate, polyvinyl alcohol, and their copolymers. Additionally, thefirst and second pad section 102, 104 may be woven or non-wovenmaterials, including 3-dimensional fabric structures. The pads may alsobe made from a sintered polymer, including materials such as sinteredpolyolefin, ethylene vinyl acetate, and fluoropolymer. The first padsection 102 and second pad section 104 may also be any other type ofopen-cell, reticulated foam, such as GranuFoam® and Whitefoam™ that aremanufactured by Kinetic Concepts, Inc. of San Antonio, Tex. If open-cellfoam is used, the porosity may vary, but is preferably about 400 to 600microns. Alternatively, gauze or any other material suited to aparticular biological application may be used to construct first padsection 102 and second pad section 104. In a certain illustrativeembodiment, first pad section 102 and second pad section 104 may beconstructed as a single, unitary pad. In another illustrativeembodiment, first pad section 102 and second pad section 104 may be amulti-component or multi-layered pad section. Preferably, thethicknesses of the first pad section 102 and second pad section 104 isfrom about 1 mm to about 50 mm, and in one implementation from about 5mm to about 20 mm, although any thicknesses may be used.

In an illustrative embodiment, the fabric layer 106 may be a woven ornon-woven fabric material known in the art, the size and shape of whichmay be varied to accommodate tissue sites of various size and shape asdescribed herein. It may be constructed from any fiber material thatmaintains its structural integrity when exposed to fluids, such aspolyamide, polyolefin, nylon, polyester, a polyamide coated withpolyurethane, any polymeric mesh, a non-woven (air layer) melt blownpolymer, or flexible sintered polymer. The fabric layer 106 may also bea fabric covered with adhesive or hydrogel to facilitate bonding to thetissue site, where the fabric layer 106 extends beyond the applicator110. The material may be woven together to form a layer of appropriatedimensions, or it may be any type of open cell mesh construction ofappropriate dimensions. As illustrated in FIG. 1, the fabric layer 106may also be folded and include stitching 140 to provide additionalchannels and structural support. A folded fabric layer may be stitchedlengthwise down the middle, as depicted in FIG. 2, around the edges, orany combination thereof. As an alternative to stitching, a folded fabriclayer may be secured with an acrylic adhesive or any other suitablebonding agent. The fabric layer 106 may also include several overlappinglayers joined together by any known means. The thicknesses of the fabriclayer 106 may be from about 1 mm to about 50 mm, or alternatively about5 mm to about 20 mm, although any thicknesses may be used.

The drape 108 may be a flexible material having a sufficiently highmoisture vapor transmission rate (“MTVR”) to preclude tissue maceration,typically greater than 600 mg/m²/day. In one aspect, plastics andthermoplastics are an example of suitable materials for the drape 108.And like the drape 108, the applicator 110 generally is constructed fromany flexible material having a sufficiently high MTVR to precludemaceration of the tissue site, such as plastics and thermoplastics.

The reduced pressure conduit 112 may represent any conduit tubing, line,or path through which a gas, liquid, gel, or other fluid may be carried,and may have more than one internal lumen. While the reduced pressureconduit 112 may be inflexible, it is preferred that it be flexibleenough for ease of use and comfort for a patient. The reduced pressureconduit is configured for connection to a reduced pressure source toprovide delivery of reduced pressure.

In an illustrative embodiment, the breathable interface systems 100,200, 500, and 600 may be lightweight, low-profile interface systems forlow-severity, small tissue sites, but the principles are readilyextendable by a person of ordinary skill in the art to larger, moreextensive tissue sites, as well as numerous other types of tissuetreatments.

Referring again to FIGS. 1-6, the aperture 302 is placed over a tissuesite and the reduced pressure source 704 delivers a reduced pressurethrough the reduced pressure conduit 112 to the breathable interfacesystems 100, 200, 500, and 600. The aperture 302 may be a singleaperture as shown, or any number or plurality of holes, openings,apertures, slits, or the like desirable for providing distribution ofreduced pressure and fluid transmission between the tissue site and thefirst pad section 102, second pad section 104, and fabric layer 106. Asdescribed above, the first pad section 102 and second pad section 104may include pathways or channels that permit the reduced pressure to bedistributed throughout the breathable interface systems 100, 200, 500,and 600, and that permit fluids to be removed from a tissue site throughthe aperture 302. The weave or mesh structure of the fabric layer 106provides additional fluid pathways that are less susceptible tocollapsing under compressive loads that may be applied to the breathableinterface systems 100, 200, 500, and 600, such as those encountered whena patient rolls in bed or otherwise moves causing compression of thedressing. The additional fluid pathways also reduce the time required todistribute reduced pressure to a tissue site. As detailed below, testinghas shown that pressure changes by a reduced pressure source arecommunicated to the tissue site much more quickly with a dressingconfigured like that of the breathable interface systems 100, 200, 500,and 600.

Referring to FIG. 7, an illustrative embodiment of a reduced pressuretissue treatment system 700 incorporating the novel features of thebreathable interface system is shown. The reduced pressure tissuetreatment system 700 includes a breathable interface system 701 similarto the other breathable interface system described herein, which isapplied to a tissue site 702 for treatment. Breathable interface system100 is fluidly connected to a reduced pressure source 704 by a reducedpressure conduit 112. In certain embodiments, the reduced pressuretissue treatment system 700 may also include a canister 706 forcollecting fluid and other non-gaseous exudates extracted from the 702.

Referring to FIG. 8, a chart that compares the results of pressuretransmission tests on a conventional dressing and a breathable interfacesystem 100 as substantially described above is shown. In the tests,reduced pressure was applied to and water was pumped through eachbreathable interface system 100 while the breathable interface system100 was subjected to a range of compressive forces. Pressuremeasurements were taken on both sides of the compressive forces todetermine the performance of each specimen. The results, as shown inFIG. 8, demonstrate that a breathable interface system 100 as describedabove enables pressure communication across the compressive load to amuch greater extent that a conventional dressing.

The flow of water was set to approximately 20 mls/hr and a compressiveforce from approximately 0 N to about 500-930 N was applied to theconventional dressing and the breathable interface system 100. They-axis 802 represents the amount of reduced pressure or vacuum measuredat either the pump or the dressing/breathable interface system 100. Thex-axis 804 represents the duration of time expired from the start of thetests. Line 806 represents the magnitude of the reduced pressure at thepump for the conventional dressing and the line 808 represents themagnitude of the reduced pressure at the opposite side of the dressing.As can be seen from FIG. 8, a compressive force of approximately 900 Nwas applied to the conventional dressing and the amount of measurablereduced pressure was approximately 0 mm Hg. at the dressing, as shown byline 808. At the start of event 814, the compressive force was released,thus the amount of measurable reduced pressure at the dressing increasedto approximately 120 mm Hg. At the end of event 814, a compressive forcewas applied at a magnitude of 525 N and the amount of measurable reducedpressure dropped back to approximately 0 mm Hg. During this same event,the measurable reduced pressure at the pump side of the dressing, asshown by line 806, stayed at approximately 125 mm Hg. This shows thatwith a conventional dressing under compressive force, the amount ofreduced pressure through the dressing is approximately 0 mm Hg.Similarly, at events 816, 818, and 820, compressive forces were releasedand reapplied at approximately 250 N. It can be seen from FIG. 8, thatessentially the same results followed. Namely, as soon as a compressiveforce was applied, the measurable amount of reduced pressure through theconventional dressing dropped to 0 mm Hg, or near 0 mm Hg.

Conversely, line 810 represents the magnitude of the reduced pressure atthe pump for the breathable interface system 100 and the line 812represents the magnitude of the reduced pressure at the opposite side ofthe dressing. As described above, a compressive force of approximately900 N was applied to the conventional dressing and the amount ofmeasurable reduced pressure was approximately 50 mm Hg at the dressing,as shown by line 812. At the start of event 814, the compressive forcewas released, thus the amount of measurable reduced pressure at thedressing increased to approximately 120 mm Hg. At the end of event 814,a compressive force was applied at a magnitude of 525 N and the amountof measurable reduced pressure was reduced to approximately 50 mm Hg.During this same event, the measurable reduced pressure at the pump sideof the dressing, as shown by line 810, stayed at approximately 125 mmHg. This shows that with a breathable interface system 100 undercompressive force, the amount of reduced pressure is still substantial.Similarly, at events 816, 818, and 820, compressive forces were releasedand reapplied at approximately 250 N. It can be seen from FIG. 8, thateven better results followed. Namely, as soon as a compressive force ofapproximately 250 N was applied, the measurable amount of reducedpressure through the conventional dressing increased to betweenapproximately 70 mm Hg. and 100 mm Hg.

Referring to FIG. 9, another chart is shown that compares response timesof a conventional dressing and a breathable interface system 100 assubstantially described above in FIG. 8 when subjected to intermittentapplication of reduced pressure under dry conditions. The response timesillustrated in FIG. 9 demonstrate that a conventional dressing respondsmuch more slowly than the breathable interface system 100 describedabove when subjected to these conditions.

Pressure measurements were taken on both sides of the compressive forcesto determine the response times of a conventional dressing compared withthe breathable interface system 100 described above. The results, asshown in FIG. 9, demonstrate that a breathable interface system 100 asdescribed above enables faster response times to the intermittentapplication and release of reduced pressure. The y-axis 902 representsthe amount of reduced pressure or vacuum measured at either the pump orthe dressing/breathable interface system 100. The x-axis 904 representsthe duration of time expired from the start of the tests. Line 906represents the magnitude of the reduced pressure measured at the pumpfor the conventional dressing and the line 908 represents the magnitudeof the reduced pressure at the opposite side of the dressing. Line 910represents the magnitude of the reduced pressure measured at the pumpfor the breathable interface system 100 and the line 912 represents themagnitude of the reduced pressure measured at the opposite side of thebreathable interface system 100.

As can be seen from FIG. 9, a reduced pressure is cycled on and offbetween approximately 0 mm Hg and 125 mm Hg. The lines 906 and 910fairly closely match each other showing that there is little differenceof measurable reduced pressure during the tests at the pump side of thedressing/breathable interface system 100 during the cycling of thereduced pressure. At the other side of the dressing, line 908 shows alag time in achieving the applied reduced pressure at the conventionaldressing. This can be seen as line 908 has an arc to its shaperepresenting the gradual building of reduced pressure before it attainsfull reduced pressure. Conversely, line 912 shows sharp transitions whenthe reduced pressure is cycled on and off, thus representing that thebreathable interface system 100 provides for improved fluid transmissionand response to reduced pressure than conventional dressings.

It should be apparent from the foregoing that an invention havingsignificant advantages has been provided. While the invention is shownin only a few of its forms, it is not just limited but is susceptible tovarious changes and modifications without departing from the spiritthereof.

1. A breathable interface system comprising: an applicator having anaperture therethrough; a drape substantially covering the applicator; afirst pad section located between the drape and the applicator; a secondpad section substantially covering the aperture and located between thedrape and the applicator, the second pad section substantially adjacentto the first pad section; and a fabric layer located at least partiallybetween the second pad section and the drape; and a reduced pressureconduit in communication with one of the first pad section and thefabric layer for providing reduced pressure to the aperture; wherein thedrape is secured to the applicator, covering the first pad section, thesecond pad section, and the fabric layer in a substantially sealedenvironment.
 2. The breathable interface system of claim 1, wherein thefabric layer is located at least partially between the first pad sectionand the applicator.
 3. The breathable interface system of claim 1further comprising an interface located between the reduced pressureconduit and at least one of the first pad section and the fabric layer.4. The breathable interface system of claim 1, wherein the first padsection and the second pad section are selected from the groupconsisting of open-cell reticulated foam, sintered polymers, ethylenevinyl acetate, fluoropolymers, polyurethane, polyolefin, vinyl acetate,polyvinyl alcohol, and their copolymers.
 5. The breathable interfacesystem of claim 1, wherein the fabric layer is selected from the groupconsisting of woven fabric, non-woven fabric, polyamide, nylon,polyamide coated with polyurethane, polymeric meshes, non-woven meltblown polymers, and flexible sintered polymers.
 6. The breathableinterface system of claim 1, wherein the first pad section, the secondpad section, and the fabric layer have a thickness of from about 5 mm toabout 20 mm.
 7. The breathable interface system of claim 1, wherein thefabric layer includes several overlapping layers joined together.
 8. Abreathable interface system comprising: an applicator having an aperturetherethrough; a drape substantially covering the applicator; a first padsection located between the drape and the applicator; a second padsection substantially covering the aperture and located between thedrape and the applicator, the second pad section substantially adjacentto the first pad section; and a fabric layer located at least partiallybetween the first pad section and the second pad section and theapplicator; and a reduced pressure conduit in communication with one ofthe first pad section and the fabric layer for providing reducedpressure to the aperture; wherein the drape is secured to theapplicator, covering the first pad section, the second pad section, andthe fabric layer in a substantially sealed environment.
 9. Thebreathable interface system of claim 9 further comprising an interfacelocated between the reduced pressure conduit and at least one of thefirst pad section and the fabric layer.
 10. The breathable interfacesystem of claim 8, wherein the first pad section and the second padsection are selected from the group consisting of open-cell reticulatedfoam, GranuFoam®, Whitefoam™, sintered polymers, ethylene vinyl acetate,fluoropolymers, polyurethane, polyolefin, vinyl acetate, polyvinylalcohol, and their copolymers.
 11. The breathable interface system ofclaim 8, wherein the fabric layer is selected from the group consistingof woven fabric, non-woven fabric, polyamide, nylon, polyamide coatedwith polyurethane, polymeric meshes, non-woven melt blown polymers, andflexible sintered polymers.
 12. The breathable interface system of claim8, wherein the first pad section, the second pad section, and the fabriclayer have a thickness of from about 5 mm to about 20 mm.
 13. Thebreathable interface system of claim 8, wherein the fabric layerincludes several overlapping layers joined together.
 14. A breathableinterface system comprising: an applicator having an aperturetherethrough; a drape substantially covering the applicator; a first padsection located between the drape and the applicator; a second padsection substantially covering the aperture and located between thedrape and the applicator, the second pad section substantially adjacentto the first pad section; and a fabric layer located at least partiallybetween the first pad section and the second pad section and the drape;and a reduced pressure conduit in communication with one of the firstpad section and the fabric layer for providing reduced pressure to theaperture; wherein the drape is secured to the applicator, covering thefirst pad section, the second pad section, and the fabric layer in asubstantially sealed environment.
 15. The breathable interface system ofclaim 14 further comprising an interface located between the reducedpressure conduit and at least one of the first pad section and thefabric layer.
 16. The breathable interface system of claim 14, whereinthe first pad section and the second pad section are selected from thegroup consisting of open-cell reticulated foam, GranuFoam®, Whitefoam™,sintered polymers, ethylene vinyl acetate, fluoropolymers, polyurethane,polyolefin, vinyl acetate, polyvinyl alcohol, and their copolymers. 17.The breathable interface system of claim 14, wherein the fabric layer isselected from the group consisting of woven fabric, non-woven fabric,polyamide, nylon, polyamide coated with polyurethane, polymeric meshes,non-woven melt blown polymers, and flexible sintered polymers.
 18. Thebreathable interface system of claim 14, wherein the first pad section,the second pad section, and the fabric layer have a thickness of fromabout 5 mm to about 20 mm.
 19. The breathable interface system of claim14, wherein the fabric layer includes several overlapping layers joinedtogether.
 20. A reduced pressure tissue treatment apparatus for applyingreduced pressure tissue treatment to a tissue site comprising: anapplicator having an aperture therethrough; a drape substantiallycovering the applicator; a first pad section located between the drapeand the applicator; a second pad section substantially covering theaperture and located between the drape and the applicator, the secondpad section substantially adjacent to the first pad section; a fabriclayer located at least partially between the second pad section and thedrape, wherein the drape is secured to the applicator, covering thefirst pad section, the second pad section, and the fabric layer in asubstantially sealed environment; a reduced pressure conduit incommunication with one of the first pad section and the fabric layer forproviding reduced pressure to the aperture; and a reduced pressuresource in communication with the reduced pressure conduit to deliverreduced pressure to the tissue site.
 21. The reduced pressure tissuetreatment apparatus of claim 20, wherein the fabric layer is located atleast partially between the first pad section and the applicator. 22.The reduced pressure tissue treatment apparatus of claim 20, wherein thefirst pad section and the second pad section are selected from the groupconsisting of open-cell reticulated foam, GranuFoam®, Whitefoam™,sintered polymers, ethylene vinyl acetate, fluoropolymers, polyurethane,polyolefin, vinyl acetate, polyvinyl alcohol, and their copolymers. 23.The reduced pressure tissue treatment apparatus of claim 20, wherein thefabric layer is selected from the group consisting of woven fabric,non-woven fabric, polyamide, nylon, polyamide coated with polyurethane,polymeric meshes, non-woven melt blown polymers, and flexible sinteredpolymers.
 24. The reduced pressure tissue treatment apparatus of claim20, wherein the first pad section, the second pad section, and thefabric layer have a thickness of from about 5 mm to about 20 mm.
 25. Thereduced pressure tissue treatment apparatus of claim 20, wherein thefabric layer includes several overlapping layers joined together.